Monday, June 20, 2016

Pediatrics "Gateway" Article Author Hiding Conflicts of Interest with Big Pharma; Drug Companies Have Gotten More than their Money's Worth

Last week, I discussed an article published in Pediatrics which is going to deal a devastating blow to the vaping industry because it wrongly concludes that e-cigarettes are a gateway to smoking among youth. Evidence like this is the death knell to vaping, as perhaps it should be if it were true.

The problem, however, is that as I explained, the Pediatrics study cannot conclude that e-cigarettes are a gateway to smoking because it measured only e-cigarette experimentation at baseline and was unable to document that a single nonsmoking vaper actually became addicted to vaping. Nor was the study able to document that a single nonsmoking vaper actually used a product that contained nicotine. Since the Monitoring the Future study suggested that a solid majority of youth e-cigarette users do not use nicotine products, this is a major study limitation.

In fact, the overwhelming evidence suggests that e-cigarettes are actually contributing towards the denormalization of smoking. The magnitude of the gateway "risk" identified in the Pediatrics paper is mathematically impossible given the recent data showing that while e-cigarette experimentation has skyrocketed among youth, smoking rates among those same youths has plummeted. Furthermore, there is now direct evidence - this time from qualitative interviews with youth - that e-cigarettes may actually be a roadblock to smoking.

Today, I reveal that what makes the Pediatrics paper even more problematic than simply its unsupported conclusions is the fact that these conclusions have the appearance of being influenced by financial conflicts of interest among one of the study authors -- conflicts that the author hid from the public.

The Rest of the Story

Clearly, there is a strong financial interest in e-cigarette research among pharmaceutical companies that manufacture smoking cessation drugs. E-cigarettes and vaping products represent enormous potential competition to the sales of cessation drugs if they prove to be effective and of reasonable risk, which would lead to more lenient regulation.

One of these companies with a financial interest in e-cigarette research is GlaxoSmithKline, maker of the following cessation drugs: nicotine gum, nicotine lozenges, nicotine patches, Wellbutrin, and Zyban. Therefore, any of the Pediatrics study authors who has received money or research funding from GlaxoSmithKline has a significant financial conflict of interest that must be disclosed in the article.

Another company with a financial interest in e-cigarette research is Pfizer, which manufactures Chantix (varenicline), a very popular and lucrative smoking cessation drug. Therefore, any of the Pediatrics study authors who has received
money or research funding from Pfizer has a significant
financial conflict of interest that must be disclosed in the article.

However, all of the authors have signed a disclosure indicating that none of them have any financial conflict of interest: the disclosure statement reads "The authors have indicated they have no financial relationships relevant to this article to disclose."

Therefore, I would take this as meaning that none of the authors have had any financial relationships, such as receiving grant funding or consultant fees, from GlaxoSmithKline, Pfizer, or any other pharmaceutical companies that market smoking cessation medications.

Hiding a Conflict of Interest - the Rest of the Story

Unfortunately, this is not the case.

One of the study authors - Dr. Jonathan Samet - was actually named in a 2011 conflict of interest lawsuit filed by Lorillard and R.J. Reynolds against the FDA, which argued that: "During the last decade, Dr. Samet has received grant support for
research and writing from GSK on at least six occasions, including in
2010. In addition, he formerly led the Institute for Global Tobacco
Control, which is funded by GSK and Pfizer. Moreover, until 2009, Dr.
Samet received regular honoraria from Pfizer for his service on the
Pfizer Global Tobacco Advisory Board."

Dr. Samet has in fact acknowledged having received grant funding from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - was funded by GlaxoSmithKline and Pfizer. Furthermore, Dr. Samet agreed "to serve on Pfizer's global tobacco control advisory board and will be compensated." Dr. Samet acknowledged serving on Pfizer's tobacco control advisory board from 2004-2009.

The journal Pediatrics adheres to ICJME policies, and under those policies, authors are required to disclose all "relationships or
activities that readers could perceive to have influenced, or that give
the appearance of potentially influencing, what you wrote in the
submitted work." This requirement does not specify that the
relationships or activities must be current or within the past 3 years.
There is no time frame given, so the clear intent here is to make sure
that authors disclose any prior history of funding from corporations
that could give the appearance of a potential conflict.

To remind readers, a conflict of interest does not represent wrongdoing, and it is
actually in the authors' best interest to err on the side of being most
inclusive. After all, conflict of interest procedures are largely in
place to protect the author and the institution, not just the journal
and the readers. Conflict of interest disclosures are not some sort of
punitive procedure, forcing authors to pay penance for past wrongdoing.
There is no wrongdoing. The sole purpose is to make sure that any
financial relationships (no matter when they occurred) that could be perceived as potentially representing a conflict are disclosed.

In large part, the reason why virtually all scientific journals have
conflict of interest policies now is this past history of failed
disclosures of scientists' ties to the tobacco companies.

It is for this reason that it becomes so imperative for us, as
scientists in the tobacco control movement, to disclose our own
conflicts of interest. It would seem highly hypocritical for us to
demand that past relationships with tobacco companies need to be
disclosed but that past relationships with pharmaceutical companies can
remain hidden. No one is suggesting that the public health implications
are the same; however, the principle is.

Ultimately, if we want the public to take seriously our efforts to
protect the integrity of science from influence by corporations which
have a vested interest in influencing the public's opinion about the
safety of their products, then it becomes critical that we set the
example by being transparent about our own conflicts of interest.

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About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.